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U.S. Department of Health and Human Services

Class 2 Device Recall SpermMar Test

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 Class 2 Device Recall SpermMar Testsee related information
Date Initiated by FirmDecember 22, 2014
Date PostedApril 15, 2015
Recall Status1 Terminated 3 on May 05, 2015
Recall NumberZ-1448-2015
Recall Event ID 70131
Product Classification Reagent, immunoassay, igg - Product Code KTO
ProductSpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
Code Information Manufacturer's Product Number/Catalog Number: SPMA_S  Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016
Recalling Firm/
Manufacturer		 Vitrolife Inc
6835 Flanders Dr Ste 500
San Diego CA 92121-3927
For Additional Information Contact
858-824-0888
Manufacturer Reason
for Recall		The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.
FDA Determined
Cause 2		Component design/selection
ActionFertiPro sent an Urgent: Medical Device Recall letter dated December 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to check if they have stock of the concerned lots and provide a confirmation that they have destroyed the affected products. Distributors were asked to inform their customers and instruct them to do the same. For further questions you may call (858) 824-0888.
Quantity in Commerce45 kits
DistributionUS Distribution to the state of : OR., and Internationally to Argentina.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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